The clinical trial results 23 October 2026 cover non-infectious uveitis, hidradenitis suppurativa, IgA nephropathy, wet AMD and metastatic colorectal cancer.
Priovant’s brepocitinib met its primary endpoint in two Phase 3 trials in non-infectious uveitis. AbbVie’s lutikizumab met its primary endpoint in hidradenitis suppurativa. The FDA granted accelerated approval to Alexion’s Ultomiris in IgA nephropathy. EyePoint’s Duravyu missed its non-inferiority primary endpoint in wet macular degeneration. XBiotech’s vilamakitug met a prespecified survival threshold but not its secondary endpoints in refractory metastatic colorectal cancer. Here, Life Science Daily News brings you the week’s most significant readouts.
Brepocitinib Meets Its Primary Endpoint in Both Phase 3 CLARITY Trials in Non-Infectious Uveitis
Roivant and Priovant Therapeutics announced the CLARITY-1 and CLARITY-2 results on 21 October. Both trials compared oral brepocitinib 45 mg once daily with placebo. Both met the primary endpoint, time to treatment failure from Week 6 to Week 48. In CLARITY-1, the hazard ratio was 0.27 (95 per cent confidence interval 0.17 to 0.43; p<0.0001). In CLARITY-2, it was 0.22 (0.14 to 0.34; p<0.0001). Cumulative incidence of treatment failure at Week 48 was 35.4 per cent versus 78.7 per cent in CLARITY-1. In CLARITY-2, it was 32.4 per cent versus 77.8 per cent. Steroid-free quiescence in both eyes at Week 48 was a key secondary endpoint. Rates were 58.8 per cent versus 19.8 per cent in CLARITY-1 (p<0.0001). In CLARITY-2, they were 64.4 per cent versus 19.4 per cent (p<0.0001). The companies reported no new safety signals, and 3 per cent of participants stopped treatment because of adverse events.
The two identical trials enrolled 166 adults in CLARITY-1 and 204 in CLARITY-2. Participants were randomised 1:1 to brepocitinib or placebo for 48 weeks of double-masked treatment. The programme is registered as NCT06431373. Every participant received oral corticosteroids at 60 mg/day for two weeks, followed by a mandatory six-week taper to zero. Priovant describes this as a more aggressive taper than in earlier uveitis trials, which limits comparison with them. The release gave no adverse event table. Brepocitinib is a TYK2 and JAK1 inhibitor, already approved as Lisraya for dermatomyositis with a boxed warning. Priovant plans to file a supplemental New Drug Application for non-infectious uveitis in the first half of 2027.
Lutikizumab Meets Its Primary HiSCR75 Endpoint in the Phase 3 INTREPID Trial in Hidradenitis Suppurativa
AbbVie reported topline results from INTREPID on 22 October. At Week 16, 31.4 per cent of patients on lutikizumab reached HiSCR75, against 23.4 per cent on placebo (p≤0.001). HiSCR75 is at least a 75 per cent reduction in abscess and inflammatory nodule count. It also requires no increase in abscesses or draining fistulas. AbbVie said lutikizumab met eight ranked secondary endpoints. Among those it quantified, skin pain responses (NRS30) at Week 8 were 36.0 per cent versus 22.8 per cent (p<0.0001). HS flares over Weeks 0 to 16 occurred in 18.4 per cent versus 28.1 per cent of patients (p<0.0001). Adverse events occurred in 53.4 per cent versus 53.7 per cent of patients. Serious events occurred in 3.0 per cent versus 2.9 per cent, and the one death was in the placebo group.
INTREPID (NCT06468228) randomised 1,400 adults and adolescents with moderate to severe hidradenitis suppurativa 1:1 to subcutaneous lutikizumab or placebo. The first 16 weeks were placebo-controlled, followed by blinded treatment to Week 52 and a 156-week open-label extension. AbbVie called it the first Phase 3 study in adults and adolescents to show a significant Week 16 HiSCR75 result. That claim is the company’s own. The release gave no confidence intervals and named only five of the eight secondary endpoints. Lutikizumab is a dual-variable-domain antibody that blocks IL-1 alpha and IL-1 beta. Further data are expected in 2027, with regulatory submissions planned for the second half of that year.
FDA Grants Accelerated Approval to Ultomiris for Proteinuria in IgA Nephropathy
AstraZeneca and Alexion announced the US accelerated approval of ravulizumab (Ultomiris) on 21 October. It is approved to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of disease progression. The approval rests on a prespecified interim analysis at Week 34 of the Phase 3 I CAN trial. The 24-hour urine protein to creatinine ratio fell 46.6 per cent from baseline with Ultomiris. The 95 per cent confidence interval was 39.0 to 53.2, and the placebo reduction was 5.6 per cent. The placebo-adjusted reduction was 43.4 per cent (95 per cent confidence interval 33.5 to 51.8; p<0.0001). The most common adverse event on Ultomiris was upper respiratory tract infection (11.3 per cent). Nasopharyngitis (9.2 per cent) and infusion-related reactions (8.4 per cent) followed.
I CAN (NCT06291376) is a global, randomised, double-blind, placebo-controlled trial, designed to enrol about 510 participants from 28 countries. The release did not report actual enrolment. Ultomiris is given intravenously every eight weeks after a loading dose. It carries a boxed warning for serious meningococcal infections. Because approval is accelerated, it is not established that Ultomiris slows kidney function decline. Continued approval may depend on the confirmatory endpoint, change in eGFR at Week 106, from the final analysis. AstraZeneca says late-breaking interim results from I CAN will be presented at ASN Kidney Week on 23 October. The company calls Ultomiris the first and only C5 inhibitor approved in the US for this use. AstraZeneca says it is the drug’s fifth indication. For other recent decisions, see LSDN’s FDA drug approval decisions tracker.
Duravyu Misses Its Non-Inferiority Primary Endpoint in the Phase 3 LUCIA Trial in Wet AMD
EyePoint announced the LUCIA topline results on 19 October. Duravyu (vorolanib intravitreal insert) did not show non-inferiority to on-label aflibercept 2 mg. The measure was change in best corrected visual acuity (BCVA) at the blended Weeks 52 and 56. The company said vision improved but gave no BCVA figures, margin, confidence interval or p-value. Secondary endpoints were more favourable. Treatment burden fell 38 per cent (nominal p<0.0001). No supplemental injection was needed in 52 per cent of eyes, and 71 per cent needed none or one. The first pivotal trial, LUGANO, also missed its primary endpoint in the full dataset. LSDN covered that result in its 21 August edition.
LUCIA (NCT06683742) enrolled 475 patients with active wet age-related macular degeneration. Patients were randomised 1:1 to Duravyu 2.7 mg every 24 weeks or aflibercept 2 mg every eight weeks. Both arms first received three monthly loading doses. Supplemental aflibercept was allowed under prespecified criteria. Vorolanib is a tyrosine kinase inhibitor that targets all VEGF receptors and PDGFR, delivered by a bioerodible insert. EyePoint then announced a strategic prioritisation. It will end both wet AMD trials early and cut about 53 per cent of its workforce. The company will now focus on diabetic macular oedema. Its Phase 3 COMO and CAPRI trials (551 patients) are due to read out in the fourth quarter of 2027. The company reported about $118 million in cash at 30 September.
Vilamakitug Meets a Survival Threshold but Not Its Secondary Endpoints in the Phase 2 TASKIN Trial in Colorectal Cancer
XBiotech reported final efficacy results from TASKIN on 19 October. The trial tested vilamakitug (XB2001), an anti-IL-1 alpha antibody, in refractory metastatic colorectal cancer. It was added to trifluridine/tipiracil with or without bevacizumab. The primary endpoint was 12-month survival, judged against a protocol threshold of at least 42 survivors among 80 patients. That threshold was met, with 49 of 80 patients (61.3 per cent) alive on vilamakitug. On control, 44 of 79 (55.7 per cent) were alive. The release reported no formal between-arm comparison for this endpoint. Time to strategy failure at 12 months was not significant (31.2 per cent versus 20.3 per cent; log-rank p=0.17). Nor was progression-free survival (median 5.9 versus 5.6 months; p=0.42).
TASKIN (NCT05201352) is an investigator-sponsored study run by Centre Georges-François Leclerc and funded by the French National Cancer Institute. Its randomised, double-blind Phase 2 portion used a Simon two-stage design, analysing 80 patients on vilamakitug and 79 on placebo. XBiotech highlighted an exploratory analysis of 37 patients with right-sided primary tumours. Their overall survival hazard ratio was 0.38 (95 per cent confidence interval 0.14 to 0.99). XBiotech describes this as a prospective exploratory analysis, and no multiplicity adjustment was reported. The confidence interval nearly reaches 1. The release linked benefit to high baseline IL-1 alpha expression but showed no biomarker data or detailed safety data. XBiotech says it is moving toward registrational development, without timelines.
Looking Ahead
This week’s clinical trial results 23 October 2026 include two clear positive readouts and one regulatory decision. The brepocitinib hazard ratios of 0.27 and 0.22 in two Phase 3 trials are the firmest data of the week. The aggressive steroid taper, however, complicates comparison with earlier uveitis studies. Lutikizumab’s 8.0 percentage point HiSCR75 gap over placebo is statistically significant but modest, and the full dataset is pending. Ultomiris shows a clear proteinuria effect. Only the eGFR result at Week 106 can show whether it protects kidney function.
The remaining two stories are weaker. Duravyu missed non-inferiority in both pivotal wet AMD trials. Without BCVA figures, the size of the shortfall is unknown. EyePoint has ended those trials and cut its workforce. Vilamakitug cleared a survival count in a small Phase 2 trial. However, the comparison was untested and the secondary endpoints were not significant. The right-sided subgroup finding is a hypothesis, not evidence of benefit. Life Science Daily News will continue to cover the readouts that matter across the global life sciences pipeline.
Read the 16 October 2026 clinical trials roundup.
